Last update 21 Nov 2024

Stapokibart

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IL-4Rα recombinant fully humanized antibody, CM310重组人源化单克隆抗体(康诺亚), Recombinant humannized monoclonal antibody (Keymed Biosciences, Inc.)
+ [4]
Target
Mechanism
IL-4Rα inhibitors(Interleukin-4 receptor subunit alpha inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CN (10 Sep 2024),
RegulationPriority Review (CN), Breakthrough Therapy (CN)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Dermatitis, Atopic
CN
10 Sep 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic rhinosinusitis with nasal polypsNDA/BLA
CN
06 Jun 2024
Rhinitis, Allergic, SeasonalNDA/BLA
CN
29 Apr 2024
Dermatitis, AtopicPhase 3-30 Aug 2024
prurigo nodularisPhase 3
CN
25 Jun 2024
AsthmaPhase 3
CN
15 Mar 2023
Pulmonary Disease, Chronic ObstructivePhase 3
CN
15 Mar 2023
Moderate Atopic DermatitisPhase 3
CN
22 Apr 2022
Severe Atopic DermatitisPhase 3
CN
22 Apr 2022
Nasal PolypsPhase 1
CN
06 Apr 2021
Alzheimer DiseasePhase 1
CN
21 Jul 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
430
Stapokibartstapokibart; 36-week maintenance treatment
(ipxwnebzsp) = jrfvjdxhts drqlzaeqvz (ixdrrfgcho )
Positive
25 Oct 2024
Placebo; 16-week double-blstapokibart +
switching from placebo to stapokibart; 36-week maintenance treatment
(ipxwnebzsp) = pxuvraypnr drqlzaeqvz (ixdrrfgcho )
Phase 2/3
72
(Healthy Volunteers)
(yjyyyrzsoj) = esxnjdrdtb hnydcsfnku (oausbznfoa )
Positive
01 Jul 2024
(Atopic Dermatitis)
(yjyyyrzsoj) = yexljyjfpz hnydcsfnku (oausbznfoa )
Phase 3
500
(ayydfohahq) = jducskgwnz elgckdmlth (kauovxdmjx )
Positive
03 Jun 2024
安慰剂转司普奇拜单抗组
(ayydfohahq) = buglidiema elgckdmlth (kauovxdmjx )
Phase 2
120
rdyylntwqx(xylbbuukrs) = cykkxfimus cyezuzplya (ikxggemfbv )
Positive
21 Jul 2023
rdyylntwqx(xylbbuukrs) = icrbsoqpob cyezuzplya (ikxggemfbv )
Phase 2
56
(oqysdercqq): LS mean difference = -7.6 (95% CI, -9.4 to -5.8)
Positive
01 Jul 2023
Placebo
Phase 3
-
(utbvnrcsfk) = 主要疗效终点均成功达到 miiyqswiii (ewypydjxoq )
Met
Positive
28 Mar 2023
安慰剂
Phase 2
56
(abuarjvruy) = ydvvovzzok hbjxfteqwk (hfzjuveiiw )
Positive
30 Mar 2022
Placebo
(abuarjvruy) = uvpzzjkiid hbjxfteqwk (hfzjuveiiw )
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